Active Ingredient
Sodium Fluoride 0.2% (w/w)............Anticavity
Mipaste
FDA Label NDC 61596-884
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gc America Inc. for the product Mipaste (NDC 61596-884). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, use, warnings, directions, other information, inactive ingredients, questions or comments?, recommended indications, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use
Aids in the prevention of dental cavities
Warnings
Keep out of reach of children under 6 years of age.
Do not use on patients with a milk protein or hydroxybenzoates allergy. In case of allergic reaction, stop use, rinse mouth with water and seek medical advice. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away.
Directions
* Adults and children over 12: brush teeth with your normal toothpaste at least twice a day, or as directed by your dental profession or doctor, rinse mouth after brushing, dispense a pea-sized portion of MI Paste Plus onto your finger, apply thoroughly, coating the upper teeth with an even layer, repeat for lower teeth, allow to remain on teeth for 3 mintues. Do not rinse.
* Children under the age of 12: consult your dental professional or doctor.
Other Information
For additional application instructions, refer to the product insert.
Inactive Ingredients
Butyl p-hydroxybenzoate, Casein phosphopeptides and amorphous calcium phosphate, D-sorbitol, Ethyl p-hydroxybenzoate, Flavoring, Glycerol, Phosphoric acid, Propyl p-hydroxybenzoate, Propylene glycol, Silicon dioxide, sodium carboxymethyl cellulose, Sodium saccharin, Titanium dioxide, Water, Xylitol
Questions Or Comments?
1-800-323-7063
Recommended Indications
To be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment. Secondarily, MI Paste Plus can be used for the management of tooth sensitivity, post-scaling, root planing and bleaching.
* Please review the disclaimer below.
